Nicholas to begin clinical studies of oncology molecule

EPP News Bureau - Mumbai

City-based pharma major Nicholas Piramal India Ltd has announced the commencement of phase I/II clinical studies of its lead anti-cancer drug molecule P276-00.

According to a release issued by the company, the permissions have been obtained from the Canadian regulatory authorities, after which a patient was infused intravenously with P276-00 at an oncology centre in Canada. The company is in the process of enrolling around 35 patients which may take around a year. This will help to determine a safe and possible efficacious dose, which will be used for further clinical studies.

Other than examining the improvements that may be observed on CT scans of the treated patients, an innovative clinical trial design is being employed which will also help evaluate the drug’s effect even at the cellular level. This will assist in further refining the strategies for additional Phase II studies in treating a cancer, the release added. P276-00 is the first in a series of compounds from the company’s research centre to enter into clinical trials.